System for patent interactive neural stimulation with robotic facilitation of limb movement

ABSTRACT

Systems and methods for patient interactive neural stimulation and/or chemical substance delivery are disclosed. A method in accordance with one embodiment of the invention includes affecting a target neural population of the patient by providing to the patient at least one of an electromagnetic signal and a chemical substance. The method can further include detecting at least one characteristic of the patient, with the characteristic at least correlated with the patient&#39;s performance of an adjunctive therapy task that is performed in association with affecting the target neural population. The method can still further include controlling at least one parameter in accordance with which the target neural population is affected, based at least in part on the detected characteristic.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.11/255,187, filed Oct. 19, 2005, now U.S. Pat. No. 7,856,264, which isincorporated herein by reference.

TECHNICAL FIELD

The present disclosure generally relates to neural stimulation and/orchemical substance delivery systems and methods in which automated orsemi-automated subsystems, devices, and/or other elements facilitatepatient performance of activities in association with neural stimulationand/or chemical substance therapies to increase the efficacy and/orefficiency associated with such therapies.

BACKGROUND

A wide variety of mental and physical processes are controlled orinfluenced by neural activity in particular regions of the brain. Forexample, the neural functions in some areas of the brain (i.e., thesensory or motor cortices) are organized according to physical orcognitive functions. In general, particular areas of the brain appear tohave distinct functions in most individuals. In the majority of people,for example, the areas of the occipital lobes relate to vision, theregions of the left interior frontal lobes relate to language, and theregions of the cerebral cortex appear to be consistently involved withconscious awareness, memory, and intellect.

Many problems or abnormalities with body functions can be caused bydysfunction, damage, disease and/or disorders in the brain. Effectivelytreating such abnormalities may be very difficult. Epidemiologicalprofiles indicate that the treatment and/or rehabilitation of neurologicdysfunction is extremely challenging due to patient populationheterogeneity, for example, due to factors such as age, gender,ethnicity, cause, physiologic location, severity, and time since onset.For most patients exhibiting neurologic damage arising from, forexample, a stroke, conventional treatments are not sufficient, andlittle can be done to significantly improve the function of an affectedbody part or cognitive function beyond the limited recovery thatgenerally occurs naturally without intervention.

A stroke is a common condition that damages the brain. Strokes aregenerally caused by emboli (e.g., obstruction of a vessel), hemorrhages(e.g., rupture of a vessel), or thrombi (e.g., clotting) in the vascularsystem of a specific region of the brain, which in turn generally causea loss or impairment of a neural function (e.g., neural functionsrelated to facial muscles, limbs, speech, etc.). Stroke patients aretypically treated using various forms of physical therapy torehabilitate the loss of function of a limb or another affected bodypart. Stroke patients may also be treated using physical therapy plusdrug treatment.

Certain types of electromechanical or robotic systems may enhanceparticular types of physical therapy rehabilitation activities. Forexample, interactive robotic devices may dynamically interface withpatients to focus on motor skills by guiding the patient through aseries of exercises. Known robotic assist devices targeting arm/handrehabilitation provide a movable member for the patient to manipulate.The robotic rehabilitation devices may provide a patient with a seriesof movements to perform with mechanical assistance and/or resistance toaid in coordination and muscular development.

Functional Electrical Stimulation (FES) generally refers to systems andmethods that apply electrical signals to peripheral nerves to restorepartial or adequate function to particular muscles in the body that areotherwise paralyzed due to damaged or dysfunctional neural signalingpathways, e.g., due to spinal cord injury, stroke, disease, or otherconditions. These conditions can break or otherwise disrupt the path orpaths by which electrical signals generated by the brain normally travelto neuromuscular groups to effectuate coordinated muscle contractionpatterns. As a result, even though the majority of nerves along a givensignaling pathway may be intact, essentially no physiological signalsare received from the spinal cord, and in turn the associated body partsdo not function. FES systems and methods attempt to compensate for thedisrupted, damaged, or dysfunctional physiological signaling pathways,and restore some function to the still intact muscles and nerves. Suchsystems and methods are known, e.g., to aid finger-grasp functions tomuscles in the arm and hand; restore control to intra-cavity muscles,e.g., in the bladder or bowel; or enhance standing and/or gait functioninvolving muscles in the hip and legs.

Although preexisting systems and methods may provide a certain level ofbenefit to individuals undergoing treatment and/or rehabilitation forneurologic dysfunction, such benefit is typically undesirably limitedand many quality of life issues still remain. There is a need forsystems and methods capable of providing more effective or sustainedneurofunctional benefit.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic illustration of a patient interactive neuralstimulation (PINS) system according to an embodiment of the inventionaccording to an embodiment of the invention.

FIG. 1B is a block diagram of a therapy management computer (TMC)according to an embodiment of the invention.

FIG. 2 is a schematic illustration of a PINS system according to anotherembodiment of the invention.

FIG. 3 is a schematic illustration of a PINS system according to anotherembodiment of the invention.

FIG. 4 is a schematic illustration of a PINS system according to yetanother embodiment of the invention.

FIGS. 5A-5F are schematic illustrations of representative types ofobjects of daily living according to an embodiment of the invention.

FIG. 6 is a schematic illustration of a patient interacting with anobject of daily living in accordance with an embodiment of theinvention.

FIG. 7 is an illustration of a PINS system according to anotherembodiment of the invention.

FIG. 8 is a schematic illustration of a PINS system according to anotherembodiment of the invention.

FIG. 9 is a schematic illustration of a PINS system directed towardproviding transcranial neural stimulation in accordance with anembodiment of the invention.

FIG. 10A is a schematic illustration of a PINS-adjunctive chemicaltherapy system according to an embodiment of the invention.

FIG. 10B is a block diagram of a TMC according to another embodiment ofthe invention.

FIG. 11A is a schematic illustration of a patient interactive chemicaltherapy system according to an embodiment of the invention.

FIG. 11B is a block diagram of a TMC according to another embodiment ofthe invention.

FIG. 12 is a flow diagram illustrating a process for interactive neuralstimulation and/or substance delivery according to an embodiment of theinvention.

DETAILED DESCRIPTION Introduction

The following disclosure describes various embodiments of patientinteractive neural therapy (PINT) systems and methods. Such systems andmethods may be directed toward restoring, developing, and/or enhancingparticular types of neural function, and/or treating or amelioratingneurologic dysfunction. Neurologic dysfunction may include disorders,diseases, injuries, and/or abnormalities related to brain and/or otherneural tissue functions. Representative types of neurologic dysfunctionmay correspond to stroke, traumatic brain injury (TBI), a pain syndrome,auditory disorders (e.g., tinnitus or auditory hallucinations), speechor language disorders (e.g., aphasia), learning disorders (e.g.,dyslexia), Parkinson's Disease, essential tremor, and/or one or moreother disorders, states or conditions.

A method for treating a patient in accordance with a particular aspectof the invention includes affecting a target neural population of thepatient by providing to the patient at least one of an electromagneticsignal and a chemical substance. The method can further includedetecting at least one characteristic of the patient, with thecharacteristic being at least correlated with the patient's performanceof an adjunctive therapy task. The adjunctive therapy task is performedin association with affecting the target neural population. The methodcan further include controlling at least one parameter in accordancewith which the target neural population is affected, based at least inpart on the detected characteristic.

In particular embodiments, detecting at least one characteristic of thepatient can include detecting a manner in which the patient performs anadjunctive therapy task. For example, this process can include detectinga motion undertaken by the patient. In other embodiments, a physiologiccharacteristic of the patient (e.g., a patient heart rate or patientblood oxygenation characteristic) can be detected. The adjunctivetherapy task can be performed at least approximately concurrently withthe process of affecting the target neural population. For example, thepatient can engage in a physical therapy task while receiving electricalstimulation of the patient's motor cortex. Controlling at least oneparameter in accordance with which the target neural population isaffected can include changing at least one parameter. For example, thisprocess can include changing the waveform of an electrical signalapplied to the patient.

Further aspects of the invention are directed to systems for treating apatient. One such system can include an adjunctive therapy device, apatient treatment delivery device that includes an electromagneticstimulator and/or a chemical delivery device, and a control systemoperatively coupled to the adjunctive therapy device and the patienttreatment device. The control system can include a computer-readablemedium having instructions for automatically receiving information fromthe adjunctive therapy device, with the information being correlatedwith the patient's performance of a task at the adjunctive therapydevice. The instructions can also automatically control a parameter inaccordance with which the patient delivery device provides treatment tothe patient, based at least in part on the information received from theadjunctive therapy device.

In particular embodiments, the adjunctive therapy device can include apatient-actuatable element and a feedback sensor. The feedback sensorcan be coupled to the control system to direct to the control system atleast one signal corresponding to the patient's manipulation of theactuatable element. The control system can control a parameter inaccordance with which the patient treatment delivery device providestreatment to the patient in an at least approximately real-time mannerrelative to receiving information from the adjunctive therapy device.

In general, PINT systems and/or methods may be directed towardmonitoring, controlling, managing, adjusting, and/or modifying one ormore manners in which neural stimulation and/or chemical substancetherapies may be provided to an individual in association with one ormore behavioral activities or therapies to possibly influence, affect,maintain, or improve therapeutic efficacy and/or efficiency. In variousembodiments, a PINT a system or method may involve 1) patientinteractive neural stimulation (PINS); 2) patient interactive neuralstimulation in association with one or more adjunctive chemicaltherapies (PINS-ACT); and/or 3) patient interactive chemical therapy(PICT), which may occur in association with one or more behavioralactivities or therapies.

Depending upon embodiment details, particular PINT systems and/ormethods may control, adjust, or modify one or more manners of deliveringneural stimulation and/or chemical substances to a patient in anadaptive or nonadaptive manner. Particular adaptive or nonadaptivemodifications may occur on a real time, near-real time basis, or delayedbasis. Adaptive modifications may be based upon patient performance orprogress in performing particular types of activities. Additionally oralternatively, adaptive or nonadaptive modifications may occur from oracross 1) one or more sets of patient tasks or activities to one or moreother task sets; 2) one treatment session to another; and/or 3) one timeperiod (e.g., a number of days, weeks, or months) to another.

Depending upon embodiment details, particular PINS systems and methodsmay correspond to transcranial, cortical, subcortical, deep brain,cerebellar, spinal column, cranial or other peripheral nerve, and/orother types of neural stimulation. Representative types of neuralstimulation that may be employed in particular embodiments include oneor more of cortical stimulation (CS), vagal nerve stimulation (VNS),deep brain stimulation (DBS), transcranial magnetic stimulation (TMS),and transcranial direct current stimulation (tDCS).

Particular types of neural stimulation devices may be partially orcompletely implanted in a patient, and may include one or more pulsegenerators coupled to a set of electrodes, electrode assemblies, and/orsignal transfer devices. Such devices may comprise, for example, acortical stimulation device as described in U.S. Patent ApplicationPublication No. 20020087201, entitled “Methods and Apparatus forEffectuating a Lasting Change in a Neural Function of a Patient,” filedon Mar. 8, 2001; a DBS device as described in U.S. Pat. No. 5,716,377;and/or a VNS device as described in U.S. Pat. No. 5,299,569, each ofwhich is incorporated herein by reference. TMS devices may comprise apulse generator coupled to a coil that is configured to generate aparticular type of magnetic field pattern. Representative types of TMSdevices may be available, for example, from The Magstim Company Ltd.,Wales, UK (www.magstim.com). One representative type of tDCS device isdescribed by W. Paulus in “Transcranial Direct Current Stimulation(tDCS)”, Transcranial Magnetic Stimulation and Transcranial DirectCurrent Stimulation (Supplements to Clinical Neurophysiology), (2003)Vol. 56, p. 249-254, which is also incorporated herein by reference.

The neural stimulation may be applied to one or more anatomicallocations. An anatomical location or region at which stimulation signalsare applied or delivered to, or through, or near a target neuralpopulation may be defined as a stimulation site. A stimulation siteand/or a target neural population may be identified and/or located in avariety of manners, for example, through one or more proceduresinvolving anatomical landmark identification; structural and/orfunctional anatomical imaging (e.g., Magnetic Resonance Imaging (MRI),Diffusion Tensor Imaging (DTI), functional MRI (fMRI), Positron EmissionTomography (PET), Magnetic Resonance Angiography (MRA), Near-infraredSpectroscopy (NIRS) or Optical Tomography (OT), orMagnetoencephalography (MEG)); electrophysiological signal measurement(e.g., electroencephalography (EEG) or electromyography (EMG));anatomical spectroscopy (e.g., Magnetic Resonance Spectroscopy (MRS));and/or other techniques. Representative manners of identifying a targetneural population and/or a stimulation site are provided in U.S. PatentApplication Publication No. US 20020087201, and U.S. patent applicationSer. No. 10/986,614, entitled “Systems and Methods for SelectingStimulation Sites and Applying Treatment, Including Treatment ofParkinson's Disease, Other Movement Disorders, and/or Drug SideEffects,” filed on Nov. 12, 2004, each of which is incorporated hereinby reference in its entirety.

In various embodiments, the neural stimulation device(s) may apply ordeliver stimulation signals to a patient. The stimulation signals mayinclude electromagnetic, acoustic, thermal, and/or other types ofsignals (e.g., mechanical forces) capable of affecting neural function.Electromagnetic stimulation signals may be defined in accordance withspatial, temporal, electrical, and/or magnetic signal parameters,properties and/or characteristics. Such stimulation signals may take onvarious forms, and may be characterized by various waveformcharacteristics (e.g., signal amplitude, duration, duty cycle, polarity,pulse width, phase information, pulse repetition frequency, and burstfrequency). Spatial, temporal, and/or waveform parameters may be variedin one or more manners to enhance a likelihood of providing,maintaining, or prolonging symptomatic relief from neurologicdysfunction. Representative types of stimulation signals and manners ofgenerating and/or varying such signals are described in U.S. patentapplication Ser. No. 11/182,713, entitled “Systems and Methods forEnhancing or Affecting Neural Stimulation Efficiency and/or Efficacy,”filed on Jul. 15, 2005, which is incorporated herein by reference in itsentirety.

In several embodiments, a PINS-ACT system may comprise a set of neuralstimulation devices configured to provide stimulation signals to a setof stimulation sites, as well as a chemical substance infusion ordelivery device (e.g., an implantable drug infusion pump) configured torelease or apply one or more chemical substances (e.g., an amphetamine,a pharmacologic agent, a neuroprotective agent, neurotrophic agent, agrowth factor, a muscle relaxant, or another substance) to a set ofdelivery sites upon or within a patient's body.

A delivery site may correspond, for example, to a target neuralpopulation or a target vascular structure. A delivery site may beidentified in a variety of manners, for example, through a set ofprocedures involving anatomical landmark identification and/or medicalimaging (e.g., Magnetic Resonance Angiography (MRA)). A representativecombined neural stimulation and drug infusion system that may beapplicable to particular PINT embodiments is described in U.S. Pat. No.6,782,292, incorporated herein by reference in its entirety.

In a related manner, a PICT system, subsystem, or device may comprise aninfusion pump and/or other substance transfer or application deviceconfigured to apply or deliver particular chemical substances to a setof delivery sites. Representative types of implantable drug pumps thatmay be applicable to particular PINS embodiments are described in U.S.Pat. No. 6,764,472 and U.S. Patent Application Publication No.20050107753, each of which is incorporated herein by reference in itsentirety.

Various embodiments of PINT systems and methods may apply or deliverparticular types of neural stimulation and/or chemical substances to apatient in association with adjunctive rehabilitative training (ART).Depending upon embodiment details, one or more types of neuralstimulation and/or chemical substances may be provided to the patientbefore, during, and/or after one or more ART sessions. Any given ARTsession may involve one or more types of ART systems, subsystems,devices, and/or elements, which may be automated or semi-automated.Particular levels of automation may allow the patient to participate orattempt to participate in therapeutic activities without the need forcontinuous or nearly continuous clinician, physician or therapistpresence during a session.

As described further below in association with various embodiments, ARTsystems, devices, or elements may be directed toward facilitating and/oreffectuating patient performance of behavioral therapies, activitiesand/or tasks such as physical therapy; physical and/or cognitive skillstraining or practice, such as training in Activities of Daily Living(ADL), intentional use of an affected body part, speech therapy, vision,visual, and/or spatial perception training, a reading task, a writingtask, an auditory activity (for example, a musical or rhythmic task ortraining), attention tasks, a cognitive activity, memory task, or memorytraining, comprehension tasks, and/or other therapies or activities.Representative types of ART devices or elements may include assistiveclothing devices, ADL devices, visual presentation or virtual realityhardware and/or software, electronic gaming devices, touch screendevices, writing tablets, and/or other devices, which may facilitate atleast some degree of physical manipulation and/or interactiveparticipation from the patient for enhanced performance of certain typesof activities involving particular neural pathways or systems,neurofunctional abilities (e.g., cognitive abilities), and/or musclegroups.

In certain embodiments, augmentative stimulation devices (ASDs) mayprovide augmentative stimulation in association or conjunction withrehabilitative, restorative, and/or therapeutic effects provided byparticular neural stimulation and/or ART devices. An ASD may provide,for example, electrical, magnetic, optical, electromechanical,mechanical, or thermal stimulation to an individual at one or moretimes. An ASD may be strategically positioned relative to one or morephysiologically relevant locations to augment compensatory, restorative,and/or rehabilitative effects. The augmentative stimulation may beprovided by devices that are implanted, external, and/or percutaneous,and may include, by way of example, functional electrical stimulation(FES), neuromuscular electrical stimulation (NMES), TMS, and/or tDCSdevices. An ASD may be operatively coupled to one or more neuralstimulation, drug delivery, and/or ART devices in a manner thatfacilitates signal communication therewith.

In accordance with several embodiments of the disclosed invention, aPINT system and/or method may facilitate patient participation in alimited duration treatment program. A limited duration treatment programmay effectuate or facilitate at least some degree of permanent,essentially permanent, or long term rehabilitation or restoration of apatient's ability to perform one or more types of physical and/orcognitive functions that had been lost or degraded due to neurologicdysfunction. Such treatment need not be directed toward managing achronic condition that exists over a very long period of time orthroughout a patient's life. Rather, the treatment may be applied over alimited time that corresponds to the extent of the patient's recovery orfunctional gain(s). A limited duration treatment program may comprise aset of treatment sessions involving one or more types of neuralstimulation and/or chemical substances in association with one or moreadjunctive therapies. Representative types of limited duration programsare described in U.S. Patent Application Publication No. US2002/0087201, entitled “Methods and Apparatus for Effectuating a LastingChange in a Neural-Function of a Patient,” filed on Mar. 8, 2001, whichis incorporated herein by reference in its entirety.

Representative PINS System Embodiments

FIG. 1A is a schematic illustration of a PINS system 1000 according toan embodiment of the invention, which may facilitate patientparticipation in a multi-modal neurofunctional development, treatment,or therapy program or regimen that involves neural stimulation and oneor more behavioral activities. In various embodiments, a PINS system1000 may comprise a neural stimulation system (NSS) 100, an adjunctiverehabilitative training (ART) device 300, and a therapy managementcomputer (TMC) 800 that is configured for signal communication with theART device 300 and possibly the NSS 100 at one or more times.

The NSS 100 may comprise one or more types of neural stimulationdevices, for example, an implantable pulse generator (IPG) 110 that iscoupled to a set of signal transfer devices, electrode assemblies,and/or electrodes 120. The NSS 100 may also comprise one or more typesof signal or substance monitoring devices, for example, an electrodeassembly configured to monitor electrocorticographic (ECoG) signals.Depending upon embodiment details, the NSS 100 may comprise fullyimplanted components that are surgically placed within a patient 10, asillustrated, and/or components that are partially implanted or externalto the patient 10.

The NSS 100 may further comprise an external programming orcommunication device 130, which in some embodiments facilitatesunidirectional or bi-directional communication (e.g., through magneticor RF telemetry) between the TMC 800 and the IPG 110. Such communicationmay involve the transfer of configuration information, programinstructions, stimulation signal parameters, power signals, and/or data.The communication device 130 may be coupled to the TMC 800 by awire-based or a wireless link 135.

In some PINT embodiments, a communication device 130 may be coupled to aprogramming device (e.g., a handheld or laptop computer, not shown)other than the TMC 800, in a manner understood by those skilled in therelevant art. In certain embodiments, a programming device such as ahandheld computer may be configured for communication with the TMC 800.Such communication may correspond in particular embodiments to theselection and/or modification of neural stimulation and/or monitoringparameters.

In addition to or as an alternative to the foregoing, in someembodiments a PINT system (such as the PINS system 1000 shown in FIG. 1Aor essentially any other type of system in accordance with the presentinvention) may comprise a patient based IPG activation device,communication puck, or patient magnet 131 to which the IPG 110 isresponsive, in a manner understood by those skilled in the art. Thepatient based activation device 131 may be carried, worn, or held by thepatient 10. In response to patient based activation, the IPG 110 maypower on or off, and/or perform particular types of neural stimulationand/or monitoring operations. The neural stimulation operations mayinvolve the application or delivery of neural stimulation signals inaccordance with one or more sets of preprogrammed stimulationparameters. A patient-based activation device and/or preprogrammed orpreselected sets of stimulation parameters, may facilitate remote orhome based therapies.

In general, the ART device 300 may comprise a set of electrical,magnetic, and/or mechanical elements, devices, and/or components thatfacilitate or effectuate patient performance of activities that arerelevant to the restoration or development of particular types ofneurofunctional abilities. Depending upon embodiment details, an ARTdevice 300 may comprise a set of devices, mechanisms, and/or structuresthat 1) the patient 10 moves or manipulates; 2) moves or manipulates oneor more patient body parts; and/or 3) provides sensory and/orproprioceptive stimulation (e.g., through the application or conveyanceof electrical, vibratory, thermal, auditory, visual, and/or olfactorysignals) to the patient 10 at one or more times.

In several embodiments, the TMC 800 comprises a computer, computersystem, and/or computer-readable medium that provides 1) an adjunctivetraining user interface corresponding to the ART device 300, where theuser interface may present audio, visual, and/or other adjunctivetraining information to the patient 10; and (in at least someembodiments) 2) a programming, control, and data transfer interfacecorresponding to the NSS 100. As further detailed below, the TMC 800 maydetermine, analyze, evaluate, estimate, and/or categorize patientperformance based upon signals received from the ART device 300. In someembodiments the TMC 800 may affect or control the application of neuralstimulation signals to the patient 10, possibly based upon the nature ofintended patient tasks and/or patient performance during one or more ARTsessions. The TMC 800 may additionally serve as a network node thatfacilitates the transfer of patient-related information to other localor remote systems or devices.

One or more of the NSS 100, the ART device 300, and the TMC 800 may varyin structure and/or function in accordance with a wide range ofembodiment details. For example, portions of one or more ART deviceelements may be implemented by particular elements of the TMC 800.Specific aspects of particular embodiments of each of the NSS 100, theART device 300, and the TMC 800 are described in detail hereafter.

Before, during, and/or after an ART session, the NSS 100 applies ordelivers one or more types of stimulation signals to one or more targetneural populations, as further detailed below. In certain instances, itmay be desirable to associate, combine, or incorporate corticalstimulation with the rehabilitation or development of one or more bodyparts, for example, an upper extremity that has been affected by astroke. Thus, in one embodiment, the NSS 100 comprises a cortical and/orother type of neural stimulation system having at least one IPG 110; oneor more electrode assemblies or electrodes 120 implanted at or relativeto a set of target neural populations, for example, particular epiduraland/or subdural cortical stimulation sites (e.g., one or more portionsof the patients motor cortex, premotor cortex, somatosensory cortex,prefrontal cortex, and/or another region in one or both hemispheres ofthe cerebral cortex 12); and possibly a set of links or lead wires 115that couple the IPG 110 to the electrode assemblies 120. In certainembodiments, the NSS 100 may comprise one or more microstimulators(e.g., a Bionic Neuron or BION®, manufactured by Advanced Bionics ofSylmar, Calif.) and possibly other microdevices, in which case the leadwires 115 may be omitted.

The IPG 110 can comprise components such as instruction processing,pulse generating, and communication circuitry that reside within abiocompatible housing. The IPG 110 can further comprise a power source(e.g., a battery and/or a capacitor) and associated power circuitry. Insome embodiments, the IPG 110 can also comprise one or more electricalcontacts or circuit completion elements that reside or are formed uponthe IPG's housing, which may facilitate a unipolar stimulationconfiguration. The IPG 110 also comprises a computer readable, operable,and/or programmable medium (e.g., a memory and/or a register set)capable of storing configuration information, program instructions,stimulation parameter information, and/or data. The pulse generatingcircuitry outputs stimulation signals, which are delivered to one ormore electrode assemblies 120 at one or more times.

An electrode assembly 120 may comprise a set of electrical contacts 122that may be carried by a substrate, and which are configured forplacement or implantation at a stimulation site. An electrode assembly120 may be of any number of dimensions, shapes and sizes and may beplaced at one or more locations as desired or indicated based upon thenature of an individual's neurologic condition. Moreover, in certainembodiments, a subset of contacts 122 may be selectively activated atparticular times and/or in various patterns to facilitate enhancedstimulation efficacy. Additional representative electrode assemblyembodiments are described in U.S. patent application Ser. No.10/742,579, entitled “Apparatuses and Systems for Applying ElectricalStimulation to a Patient,” filed on Dec. 18, 2003, incorporated hereinby reference in its entirety.

As indicated above, the NSS 100 may also comprise a programming orcommunication device 130 that facilitates or effectuates unidirectionalor bi-directional signal communication with the TMC 800. Thecommunication device 130 may comprise, for example, a housing in which acoil and wireless communication circuitry reside. In some embodiments,the TMC 800 may initiate, continue, adjust, query, interrupt, restart,and/or discontinue neural stimulation by issuing or outputting one ormore commands, instructions, and/or parameters that are transferred tothe IPG 110 by way of the communication device 130. The TMC 800 mayissue such commands based upon signals received from an ART device 300during one or more ART sessions.

The ART device 300 may comprise various types of components thatfacilitate and/or effectuate the movement, manipulation, and/or sensorystimulation of an affected limb such as a hand 22 and/or an arm 20 asshown in the instant Figure. In one embodiment directed toward therestoration or development of hand/wrist function, the ART device 300comprises a base 310, an armrest 312, and a joystick or joystick-typemechanism 320. The ART device 300 is coupled to the TMC 800 by a link325, which may be wire-based or wireless.

During an ART session, the joystick 320 may be grasped by the patient'shand 22 and moved, manipulated, directed, carried, and/or rotatedthrough one or more types of movements or movement patterns. In someembodiments, during one or more portions of a movement or movementpattern, the joystick 320 may apply assistive, resistive/opposing,stabilizing, and/or destabilizing forces to the patient's hand 22 toaffect the patient's hand movements or movement patterns. The joystick320 may include one or more buttons and/or levers that are responsive tofinger or thumb pressure. Such buttons or levers may have programmablyassigned functionality, in a manner understood by those skilled in therelevant art.

As described in greater detail below, the TMC 800 may present auditoryand/or visual (A/V) adjunctive training information (e.g., instructionsor motivational patient performance feedback) to the patient 10; and/orthe joystick 320 may apply or convey particular sensory stimuli to thepatient 10. The auditory, visual, and/or other sensory stimuli maycorrespond to a video game, a virtual reality presentation, educationalinformation, a cognitive task or test, and/or essentially any type ofactivity or task that is relevant to improving the patient'sneurofunctional condition. The patient 10 is expected or encouraged tointeractively respond to such stimuli using the joystick 320.

Depending upon embodiment details or the nature of an individual'sneurologic condition and/or neurofunctional development progress, theIPG 110 may output stimulation signals during one or more portions of anART session in a manner that is independent of or dependent upon signalsthat the TMC 800 receives from the ART device 300, as further describedbelow.

FIG. 1B is a block diagram of a TMC 800 according to an embodiment ofthe invention. Relative to FIG. 1A, like reference numbers correspond tolike elements. In one embodiment, the TMC 800 comprises a computersystem having at least one processing unit 802; a data storage unit 804;a set of input/output (I/O) interfaces 806; a set of input devices 810;a set of output devices 820; a network interface unit 830; and a memory840 wherein an operating system 842, an adjunctive training unit (ATU)850, a performance assessment unit (PAU) 860, and a stimulation controlunit (SCU) 870 reside. Particular elements of the TMC 800 may be coupledto a set of common buses 880 in a manner understood by those skilled inthe art.

The TMC 800 may also be coupled a network 890, which may comprise one ormore of a Local Area Network (LAN), a Wide Area Network (WAN), theInternet, a telephone network (e.g., the Public Switched TelephoneNetwork (PTSN) and/or a cellular network), a satellite network, and/oranother type of communication infrastructure that facilitatesinteractive, real-time, isochronous, and/or delayed informationtransfer. In some embodiments, the network 890 may facilitateinformation transfer to and/or from one or more network attached storage(NAS) devices, servers or server farms, and/or databases (e.g., amedical database).

The processing unit 802 may comprise a microprocessor capable ofexecuting program instructions. The data storage unit 804 may compriseone or more fixed and/or removable data storage media, for example, ahard disk drive capable of storing program instructions and/or data. Theset of I/O interfaces 806 may comprise one or more standard and/orproprietary I/O interfaces, for example, a Universal Serial Bus (USB)interface, an IEEE-1394 or Firewire™ interface, a serial port, and/or aparallel port.

The set of I/O interfaces 806 may be coupled to a set of input devices810, a set of output devices 820, one or more ART devices 300, andpossibly one or more NSS communication devices 130. In certainembodiments, a single TMC 800 may manage or direct multiple local orremote ART sessions, possibly in a simultaneous or nearly simultaneousmanner. The set of I/O interfaces 806 may include hardware (e.g., avideo card) and/or software (e.g., drivers) that facilitatecommunication with particular types of devices. The set of input devices810 may comprise one or more of a keyboard 812 and a mouse 814, a cameraor image capture device 816, a microphone 818, and/or another type ofdevice. The set of output devices 820 may comprise one or more of adisplay device (e.g., a computer monitor) 822, a set of speakers 824,and/or another type of device.

The memory 840 may comprise a computer readable, operable, and/orprogrammable medium having one or more types of volatile and/ornonvolatile data storage elements, for example, a Random Access Memory(RAM) and a Read Only Memory (ROM). The operating system 842 maycomprise a set of programming instructions that manage access to TMCsystem-level hardware and/or software resources, in a manner understoodby those skilled in the art.

The ATU 850 may comprise a set of program instructions that generates ormanages the presentation of adjunctive training information to thepatient 10. The ATU 850 may comprise program instructions correspondingto or directed toward implementing and/or managing a video game; avirtual reality environment or activity scenario; various types ofphysical and/or cognitive tasks; standardized or customizedneurofunctional capability or assessment tests; and/or other activities,situations, tasks, or tests.

The PAU 860 may comprise a set of program instructions that receives,analyzes evaluates, categorizes, and/or stores patient performanceinformation associated with one or more ART sessions. Depending uponembodiment details, the patient performance information may comprisesignals received from one or more ART devices 300, still and/or videoimages captured by a camera 816, scores associated with performanceevaluation tests, and/or other information. The PAU 860 may analyze suchinformation on a regular or periodic basis, and/or in response to arequest received from a medical professional or the patient 10. Incertain embodiments, particular patient performance information may bedefined, analyzed, and/or stored at a remote location (e.g., by programinstructions executing upon a remote computer coupled to the network890).

The SCU 870 may comprise a set of program instructions that manage theapplication or delivery of neural stimulation signals to the patient 10.As elaborated upon below, the SCU 870 may manage the issuance of signalsto and/or the receipt of signals from the NSS 100, possibly based uponpatient performance as determined or estimated by the PAU 860.

The ATU 850, the PAU 860, and/or the SCU 870 may operate in a widevariety of manners to facilitate a patient's neurofunctional developmentthrough neural stimulation in association with automated and/orsemi-automated interactive patient activities. Particular manners inwhich the ATU 850, the PAU 860, and/or the SCU 870 may direct or managepatient interactive neural stimulation are described in detail below.

FIG. 2 is a schematic illustration of a PINS system 1002 according toanother embodiment of the invention. In various embodiments, a PINSsystem 1002 may comprise a neural stimulation system (NSS) 102, anassistive clothing ART (AC-ART) device 400, and a TMC 800 configured forsignal communication with the AC-ART device 400 and/or the NSS 102 atone or more times.

In several embodiments, the structure and/or function of the NSS 102 andTMC 800 may be identical, essentially identical, or similar to thatdescribed above with reference to FIGS. 1A and 1B, and hence like oranalogous reference numbers may indicate like or analogous elements. Inthe instant Figure, the NSS 102 may comprise a set of electrodeassemblies 120 a, 120 b, at least one of which includes a set ofelectrical contacts 122. A given electrode assembly 120 a, 120 b may beimplanted at or relative to one or more anatomical locations, and mayapply stimulation signals, and/or detect, sense, monitor, or measureparticular types of physiologic or physiologic correlate signals,chemical substance levels, temperature, and/or other information.Depending upon embodiment details, a set of lead wires 115 may couplethe electrode assemblies 120 a, 120 b to one or more pulse generators110.

In some embodiments, signals may be communicated to and/or received fromtwo or more neuroanatomical locations, which may correspond to the sameor different brain hemispheres. Electrode assemblies 120 a, 120 b may beimplanted at neurological locations that may be functionally related(e.g., associated by way of a temporally-sequenced neural signalingpathway; or in homologous locations), generally distinct, or distinct.In a general example, an electrode assembly 120 a may be positioned ator relative to an epidural and/or subdural cortical location that isfunctionally responsible for movement of an affected limb. Anotherelectrode assembly 120 b may be placed at a neurological location thatis functionally responsible for providing neurological sensoryinformation corresponding to the affected limb, such as an arm 20 and/oranother body part.

As another representative example, one or more electrode assemblies 120a positioned at or relative to particular neuroanatomical locations(e.g., a set of cortical, subcortical, and/or spinal cord locations) mayapply stimulation signals, and one or more other electrode assemblies120 b positioned at or relative to certain anatomical locations maysense or measure particular types of signals, for example, ECoG,cerebral blood flow (CBF), blood composition or, oxygenation state, EMG,and/or other types of signals. Sensing or monitoring activity may occurin the vicinity of the neural stimulation, and/or at other locations.

In various embodiments, the AC-ART device 400 may comprise anapparel-type device that is positioned relative to and/or worn upon anaffected limb or extremity, such that it facilitates patient performanceof behavioral therapy and/or rehabilitation activities during one ormore therapy periods, treatment sessions, or training sessions. Thepatient 10 may participate in such activities in a clinical setting, orin another setting such as a home environment. Patients 10 experiencingneurologic dysfunction associated with hemiparesis, spasticity, neglect,bradykinesia, and/or other conditions may benefit from an AC-ART device400 configured to provide physical, sensory, and/or proprioceptivemanipulation or stimulation of body parts such as an arm 20, a hand 22,and fingers 24, and possibly lower extremity body parts such a legand/or a foot. A representative type of assistive clothing device thatmay be suitable for use in particular embodiments of the invention isdescribed in detail in US Patent Application Publication No.2003/0120183, entitled “Assistive Clothing,” incorporated herein byreference in its entirety.

In certain embodiments, the AC-ART device 400 may comprise a wearablesleeve apparatus 410 coupled to a controller 450 by a wire-based orwireless link 452. Depending upon embodiment details, one or moreportions of the controller 450 may be separate from, carried by, orintegral with the sleeve apparatus 410. The controller 450 may furtherbe coupled to the TMC 800 by another wire-based or wireless link 454.Additionally or alternatively, in certain embodiments one or moreportions of the controller 450 may be implemented by particular elementsof the TMC 800.

As shown, an AC-ART device 400 may be worn about portions of a patient'slimb(s) 20, for example, the arm 20, wrist, and/or hand 22, toselectively facilitate and/or inhibit particular types of movement ormotion. For example, the patient 10 may wear the AC-ART device 400 byplacing the sleeve apparatus 410 about an arm 20 and hand 22. The sleeveapparatus 410 may comprise support materials that surround, hold, orcarry portions a limb 20; as well as one or more motion or activityfacilitation devices, mechanisms, or structures. Depending uponembodiment details, motion facilitation or motion control devices mayinclude translational actuators 412, rotational actuators 414, rotationcuffs 416, pivots 418, cables or cords 420, electrical couplings 424,and/or other elements that facilitate, direct, or manage the rotation,flexion, or extension of the patient's arm, wrist, and/or hand 22,possibly based upon an extent to which a patient 10 can independently orsuccessfully perform one or more movements as further described below.Several types of motion control devices (e.g., actuators 412, 414) maybe responsive to signals or commands received from the controller 450.

The AC-ART device 400 may additionally comprise a set of sensors 430that facilitate sensing, detection, measurement, monitoring,characterization, outputting, and/or control of positions, orientations,velocities, forces, and/or other information corresponding to particularportions of the sleeve apparatus 410 in one or more directions ordimensions. In several embodiments, particular types of sensors 430(e.g., ultrasonic transducers; force, torque, or pressure sensors;accelerometers; EMG electrodes, and/or other devices) may be carried bythe sleeve apparatus 410. Additionally or alternatively, in someembodiments, one or more portions of certain sensors 430, sensingelements, or sensing systems may be separate from the sleeve apparatus410 (e.g., a set of room-based radio frequency (RF) position/orientationsensors). In certain embodiments, actuators 412, 414, rotation cuffs416, and/or other elements may be capable of receiving and/or outputtingsuch information.

The actuators 412, 414, rotation cuffs 416, and cables 420 may belocated upon or about the sleeve apparatus 410 in a manner thatfacilitates or controls an intended range or type of body part motion,thereby facilitating patient performance of activities that may berelevant to rehabilitating, restoring, or augmenting certainneurofunctional abilities. In various embodiments, the translationalactuators 412 may be configured with cables 420 to facilitatetranslational motion and the rotation cuffs 416 may be configured withrotational actuators 414 to facilitate rotational motion betweenparticular portions of the sleeve apparatus 410. Electrical couplings424 may facilitate signal transfer between particular actuators 412, 414and the controller 450, and/or between actuators 412, 414 themselves.

In a representative embodiment, one or more actuators 412, 414 maycomprise a set of stepper motors configured to provide or apply forcesin lateral, longitudinal and/or oblique or diagonal directions. Althoughelectromechanical actuators are described in relation to thisembodiment, it is to be appreciated that other types of actuatorssuitable for use in various embodiments may comprise pistons, magneticmechanisms, and/or other devices without departing from the scope of theinvention.

In some embodiments, one or more pivots 418 may be carried by or locatedupon the device 410 to generally coincide with a bending point on thepatient's limb, and may likewise be coupled to certain cables 420 tofacilitate such motion. For instance, in this illustrated example, apivot 418 may facilitate bending motion at an elbow. However, inasmuchas an AC-ART device 400 may be worn about other body parts (e.g., thelegs or torso), a pivot 418 may be configured to correspond to otherbending locations (e.g., knees, ankles, or the hip area).

The controller 450, e.g., in association with the TMC 800, may initiate,measure, increase, decrease, interrupt, continue, or terminate theapplication of forces to the sleeve apparatus 410 to enable, oppose,and/or characterize particular patient motions. The controller 450 maycomprise hardware and/or software sending information to and/orreceiving information from the sleeve apparatus 410. Such informationmay comprise, for example, commands directed to particular actuators412, 414 or rotation cuffs 416, or position/orientation signals receivedfrom one or more sensors 430. The controller 450 may also comprisehardware and/or software for sending information to and/or receivinginformation from the TMC 800. For example, the controller 450 maytransfer real time, near-real time, and/or stored or time stampedactuator force data, sleeve apparatus position/orientation measurements,and/or other information to the TMC 800. As another example, the TMC800, possibly based upon current and/or past sleeve apparatusposition(s) or patient performance, may transfer fully and/or partiallyassistive or resistive motion commands; fully and/or partially assistiveor resistive motion scripts, programs, or corresponding identifiers(IDs); performance monitoring requests; and/or other information to thecontroller 450.

In various embodiments, the controller 450 may comprise one or moreprocessing units; one or more types of electronically readable,writable, and/or programmable media (e.g., a fixed and/or a removablememory, a set of buffers, and the like), which may store programinstructions and/or data; signal conversion circuitry (e.g., analog todigital (ND) converters); signal communication circuitry (e.g., I/Ocircuitry, software drivers, wireless or wire-based communication ports,and the like); and/or other elements.

The TMC 800 may comprise a computer system configured to communicatewith the controller 450 and/or the NSS 100 at one or more times.Depending upon embodiment details, the TMC 800 may be configured andadapted to facilitate one or more of the following:

-   -   1) Communication with the NSS 100, which may involve the        transfer of neural stimulation parameters, commands directed        toward a pulse generator or implanted monitoring device,        physiologic or physiologic correlate information corresponding        to such monitoring devices, patient data, and/or other        information. Through such communication, the TMC 800 may        initiate, continue, query, adjust, monitor, interrupt, and/or        terminate neural stimulation and/or implanted device monitoring        operations before, during, and/or after particular portions of a        therapy period or treatment session.    -   2) Communication with the controller 450, which may involve the        transfer of commands, requests, scripts or script IDs, sleeve        apparatus parameters (e.g., applied or measured force signals or        data, position/orientation data, and the like), and/or other        information.    -   3) Presentation of information to the patient 10. Such        information may comprise auditory and/or visual patient        instructions, ideal or example movement patterns, images, or        image sequences, interactive virtual reality situations        involving particular behavioral activities, patient motions, and        situational goals or targets, real time or near-real time        patient movement images 805, visual and/or auditory patient        performance feedback, which may include motivational or behavior        reinforcement feedback, and/or other information.    -   4) Acquisition (e.g., using an image or video capture device        816), storage, retrieval, measurement, characterization, and/or        analysis of patient related information (e.g., sleeve apparatus        signals corresponding to an extent to which the patient 10        performs particular reaching, pointing, grasping, pushing,        pulling, lifting, releasing, or other tasks).    -   5) Selection or modification of virtual reality situations,        behavioral activities, and/or sleeve apparatus scripts, script        IDs, or parameters (e.g., applied forces), possibly based upon        actual or estimated current and/or past patient performance.    -   6) Remote communication of patient-related information, which        may involve the transfer of information to a networked computer        system or device (e.g., used by a clinician or physician),        and/or the receipt of commands, instructions, messages (e.g., an        A/V message) and/or other information from a networked computer        system.

In general, a treatment program or regimen may specify or indicate oneor more sets of therapy period or treatment session parameters. Suchparameters may correspond to therapy period or treatment sessionduration, particular behavioral activities, sensory stimuli, neuralstimulation parameters, implanted device monitoring instructions, and/orAC-ART device parameters across one or more time domains (e.g., asubseconds-based, a seconds-based, an hours-based, a week-based, amonth-based, or other time domain). One or more portions of a treatmentprogram may be based on human and/or PINS-based assessments of thepatient's neurofunctional capabilities.

In various situations, new or updated therapy period or treatmentsession parameters may be needed or desirable. Such situations mayarise, for example, when a patient 10 is a first-time user; initial orperiodic measurement or estimation of a patient movement threshold(e.g., using of EMG electrodes or sensors 430 to detect patient motion)is desirable (e.g., once per session or once per week) to facilitatedetermination of certain neural stimulation parameters (e.g., peakcurrent level, pulse repetition frequency, and/or pulse width);particular patient functional gains have begun to plateau or peak;and/or the patient 10 is resuming a treatment program following aninterruption period (e.g., after a rest, strengthening, or neuralconsolidation period). In various embodiments, TMC 800 and/or thecontroller 450 may initiate a diagnostic session to determine variousparameters.

In some embodiments, the TMC 800 may direct the NSS 100 to apply neuralstimulation signals and/or activate implanted monitoring devices duringone or more portions of a diagnostic session. Additionally, the TMC 800and/or the controller 450 may acquire, sense, monitor, or measurepatient motion, activity, and/or responses. In certain embodiments,during a diagnostic session the TMC 800 and/or the controller 450 mayspecify or select particular types of test exercises or movements forthe patient 10 to perform using the sleeve apparatus 410.

The TMC 800 may acquire, retrieve, store, characterize, and/or analyzediagnostic session information, and possibly transfer diagnostic sessioninformation to a remote location for clinician or physician analysis.Based upon diagnostic session information analysis, a medicalprofessional and/or the TMC 800 may select, define, or adjust therapyperiod or treatment session parameters.

The nature of a therapy period or treatment session may vary based uponthe patient's neurofunctional condition; current and/or past patientcapabilities, performance, and/or progress; and/or embodiment details.In some embodiments, during a treatment session the AC-ART device 400may completely or partially guide or carry the patient 10 through one ormore movement patterns before, during, and/or after the NSS 100 appliesneural stimulation to the patient 10. Additionally or alternatively, theAC-ART device 400, possibly in association with the TMC 800, may adjustor adapt various types (e.g., assistive or oppositional longitudinal orrotational) of forces applied by the sleeve apparatus 410 at one or moretimes to facilitate patient performance of assisted, partially assisted,unassisted, partially opposed, and/or opposed patient movements. Mannersin which such forces are applied may be based upon current or pastpatient performance or capabilities. In certain embodiments, the TMC 800may initiate, continue, query, adjust, interrupt, or discontinue theapplication of neural stimulation signals to the patient 10 before,during, and/or the patient performs or attempts particular movements,possibly based upon present or prior patient-related information. TheTMC 800 may further manage or direct the application of neuralstimulation to the patient 10 in an anticipatory or approximatelyanticipatory manner based upon expected and/or prior patient movements.

In particular embodiments, the TMC 800 and/or the controller 450 mayacquire, receive, characterize, and/or analyze signals from one or moresensors 430 to determine or estimate patient capabilities (e.g.,assisted, partially assisted, or unassisted range of motion limits ormovement duration) and/or patient exertion level at one or more times.The TMC 800 may additionally receive, characterize, and/or analyzesignals from a set of implanted monitoring devices to determine orestimate changes in patient state information, such as changes inbrainwave patterns (e.g., which may be associated with a level ofpatient concentration, exertion, or fatigue) corresponding to particularactivities, performance results, times, and/or time intervals.

FIG. 3 is a schematic illustration of a PINS system 1004 according toanother embodiment of the invention. In various embodiments, a PINSsystem 1004 may comprise a neural stimulation system (NSS) 100; arobotic ART (Rob-ART) system, apparatus, or device 500; a TMC 800; andpossibly a secondary stimulation and/or monitoring (SSM) system ordevice 150. The TMC 800 may be configured for signal communication withthe Rob-ART device 500, the NSS 100, and/or the SSM system 150 at one ormore times.

In a manner identical or analogous to that described above withreference to FIGS. 1A and 2, the NSS 100 may comprise a set of neuralstimulation devices, for example, one or more electrode assemblies 120coupled to an IPG 110. The NSS 100 may be adapted for bi-directionalcommunication with a communication device 130. In several embodiments,the communication device 130 is coupled to the TMC 800, therebyfacilitating the transfer of configuration information, programinstructions, stimulation signal parameters, power signals, and/or databetween the TMC 800 and the NSS 100. As further described below, in suchembodiments the TMC 800 may initiate, query, modify, interrupt, resume,continue, or terminate operation of the NSS 100, possibly based uponinformation (e.g., signals corresponding to patient performance)received from the Rob-ART device 500. In some embodiments, thecommunication device 130 may additionally or alternatively be configuredfor wire-based or wireless communication with a programmer (e.g., ahandheld computer, not shown), which itself may be configured forwire-based or wireless communication with the TMC 800.

In general, a Rob-ART device 500 may comprise one or more types ofrobotic systems, devices, and/or elements configured and adapted toenable, assist, resist, and/or oppose particular type of body part(e.g., hand, arm, leg, or foot) motions or movement patterns. A Rob-ARTdevice 500 may further comprise particular types of sensing ormonitoring devices or elements (e.g., force, velocity, and positionsensors) that facilitate the generation, retrieval, measurement,analysis, and/or characterization of Rob-ART motion-related signalscorresponding to patient movements or patient performance. A Rob-ARTdevice 500 additionally comprises a controller for directing or managingthe operation of its robotic and sensing elements. The controller maycomprise hardware (e.g., signal conversion circuitry; a computerreadable or programmable medium; an instruction and/or signal processingunit or microcontroller; and power/power management circuitry) andsoftware, in a manner understood by those skilled in the art. TheRob-ART controller may be separate or generally separate from the TMC800; and/or may comprise particular elements (e.g., a set of circuitboards carrying integrated circuits that facilitate Rob-ART operation)of, within, or carried by the TMC 800.

In various embodiments, a Rob-ART device 500 may guide, carry, move, ormanipulate particular body parts (e.g., a hand, arm, leg, or foot) inaccordance with motion patterns that are expected to be therapeutic. Insome embodiments, a Rob-ART device 500, possibly in association with theTMC 800, may enable, assist, resist, or oppose particular types ofpatient motion based upon an extent to which the patient 10 canindependently or successfully perform such motions. An extent to whichthe patient 10 can independently or successfully perform particularmotions may be indicated by signals generated or measured by one or moreRob-ART elements (e.g., actuators or sensors), where such signals may beanalyzed or characterized by the Rob-ART controller and/or the TMC 800.In certain embodiments, the TMC 800 may communicate with the NSS 100 toestablish or adjust particular neural stimulation parameters based uponpresent or historical patient performance.

In embodiments such as that shown in FIG. 3, a Rob-ART device 500 maycomprise a set of arm members 510 a-c; one or more elbow joints 512coupled to arm members 510 a-c to form rotational axes; a set ofactuators 520 a-c configured to facilitate particular types of armmember motion; a set of sensors 530 configured to sense and quantifyposition, force, speed, and/or other information corresponding toparticular arm members 510 a-c or elbow joints 512; at least onegripping portion 515 configured for grasping by a patient's hand(s) 22;a support base 540; and a control unit 580 that is coupled to theactuators 520 and the sensors 530. The control unit 580 may further beconfigured for wire-based or wireless communication with the TMC 800,such as by way of a link 582. The control unit 580 may execute commands,instructions, or programs; transmit actuator and/or sensor commands;monitor, receive, process, and/or analyze actuator and sensor signals;and possibly communicate with the TMC 800 to facilitate or effectuateRob-ART device operation. In a representative embodiment, one or moreportions of the Rob-ART device 500 may be based upon or implementedusing a type of robotic therapy device described in U.S. Pat. No.5,466,213 entitled, “Interactive Robotic Therapist”, which isincorporated herein by reference in its entirety.

The Rob-ART device 500 may provide one or more types of activitiesrelevant to the restoration or development of neurofunctional abilitiesassociated with the patient's hand 22 and/or arm 20. In situations wherea patient's dysfunction may prohibit them from grasping the grippingportion 515 sufficiently on their own, the Rob-ART device 500 mayinclude an adaptation apparatus (not shown) to attach or couple thepatient's hand 22 and/or arm 20 to particular portions (e.g., an armmember 510 a) of the Rob-ART device 500.

The TMC 800 comprises a computer system having a structure and/orfunction that is identical, essentially identical, or analogous to thatdescribed above with reference to FIGS. 1A, 1B, and 2. For example, theTMC 800 may communicate with the NSS 100 to initiate, query, continue,adjust, interrupt, resume, or discontinue neural stimulation and/ormonitoring operations. The TMC 800 may also communicate information tothe patient 10, such as auditory or visual instructions (e.g., still orvideo images indicating how a movement or motion sequence should beperformed). In certain embodiments, the TMC 800 may manage, respond to,initiate, adjust, interrupt, resume, continue, or terminate Rob-ARTdevice operation. Additionally, the TMC 800 may select particularRob-ART programs or scripts for therapeutic and/or patient testing orevaluation purposes, possibly in an adaptive or patient performancedependent manner. The TMC 800 may further capture, receive, store,analyze, characterize, and/or transfer (e.g., to a networked system ordevice) patient-related information, including patient performancesignals, images, and/or videos. The TMC 800 may additionally provide orpresent auditory or visual feedback (e.g., by playing an audio or videofile that includes therapist or clinician comments) to the patient 10.

As indicated above, in several embodiments a PINT system may comprise anSSM system or device 150, which may be configured for wire-based and/orwireless communication with the TMC 800 and/or an ART system or device.Such embodiments may include the PINS system 1004 illustrated in FIG. 3,as well as other PINS and/or PICT embodiments relating or correspondingto particular Figures described herein. In general, an SSM device 150may provide stimulation signals to the patient 10; and/or detect,monitor, or measure patient state or patient response signals. Dependingupon embodiment details, the stimulation signals may compriseelectromagnetic, vibratory, thermal, and/or other types of signals.Patient state or response signals may comprise EEG or EMG signals;structural and/or functional imaging signals (e.g., MRI, fMRI, PET,optical imaging, or MEG signals); intrinsic or extrinsic patient motionsignals (e.g., as detected by an accelerometer or gyroscope); and/orsignals corresponding to temperature, pulse rate: blood pressure, bloodoxygenation or composition characteristics, blood flow, and/or otherpatient parameters.

Depending upon embodiment details, an SSM system 150 may applystimulation signals and/or detect patient state or response signals ator relative to various anatomical locations based upon signal type andSSM element configuration. For example, in some embodiments, the SSMsystem 150 may generate or output electromagnetic signals directedtoward Functional Electrical Stimulation (FES), and detect or measureEMG signals corresponding to muscle innervation at a patient's arm 20 orother extremity. In such embodiments, the SSM system 150 comprises a setof stimulation electrodes 152 and a set of sensing electrodes 154 thatare configured for signal communication with a control module 156, forexample, by way of stimulation and sensing links 153, 155 respectively.

Depending upon embodiment details, the control module 156 may comprisehardware (for example, communication circuitry, instruction and/orsignal processing circuitry, an electronically readable or programmablemedium (e.g., a memory), signal conversion circuitry, pulse generatingcircuitry, and power/power management circuitry) and software thatfacilitate the receipt and analysis of EMG signals and the selectiveoutput of electromagnetic stimulation signals. The control module 156may be coupled to the TMC 800 and/or the Rob-ART device 500 such thatthe TMC 800 and/or the Rob-ART device 500 may track and/or managecertain aspects of SSM system operation. The control module 156 maycommunicate with the Rob-ART device 500 (e.g., by way of a link 585),and/or the TMC 800 (e.g., by way of another link 157), in accordancewith one or more custom or standardized signal transfer protocols (e.g.,a packet or message based protocol), in a manner understood by thoseskilled in the art.

In some embodiments, the control module 156 may transfer sensed EMGsignals to the TMC 800 and/or the Rob-ART device 500 at one or moretimes. Depending upon embodiment details, the TMC 800 may adjust neuralstimulation parameters; or the TMC 800 and/or the Rob-ART device 500 mayadjust Rob-ART device operation at one or more times in a manner thatcorresponds to such EMG signals. Additionally or alternatively, inresponse to sensed EMG signals, the TMC 800 and/or the Rob-ART device500 may command the SSM system 150 to apply or deliver a set of FESsignals to the patient 10, possibly based upon 1) an actual, estimated,and/or inferred position or orientation of a patient extremity such asan arm 20; 2) one or more corresponding actual, estimated, and/orinferred muscle or muscle group states; 3) an extent to which thepatient 10 can spatially and/or temporally move, manipulate, or directthe Rob-ART device 500 in an independent or successful manner; 4) anactual, estimated, or inferred time at which the NSS 100 delivers orapplies neural stimulation signals to one or more stimulation sites;and/or 5) a measured or estimated nerve signal conduction time orlatency between an NSS stimulation site and an FES stimulation site.Such a nerve signal conduction time may be determined through a set ofevoked potential tests prior to a therapy period or treatment session,for example, using TMS and EMG, in a manner understood by those skilledin the art.

In certain embodiments, the SSM system 150 may comprise a set ofmicrostimulators (e.g., one or more BIONS®) implanted relative toparticular muscle and/or nerve locations to apply FES and/or detectnerve action potentials. The SSM system 150 may include a wirelesscommunication device (e.g., a coil) that is coupled to a handheld,stand-alone, or other type of control module 156 to facilitate signaltransfer to and/or from particular microstimulators. In a representativeembodiment, such an SSM system 150 may be implemented in a mannerdescribed or indicated in U.S. Patent Application No. 2005/0137648,entitled “System and Method Suitable for Treatment of a Patient with aNeurological Deficit by Sequentially Stimulating Neural Pathways Using aSystem of Discrete Implantable Medical Devices”, which is incorporatedherein by reference in its entirety.

In addition or as an alternative to an FES and/or EMG based system,representative types of SSM systems 150 may comprise or be based upon anOxiplexTS™ tissue spectrometer manufactured by ISS, Inc., of Champaign,Ill.; an Imagent™ optical imaging system, also manufactured by ISS,Inc.; or a Geodesic EEG System having a Hydrocel Geodesic Sensor Net®manufactured by Electrical Geodesics, Inc., of Eugene, Oreg.

FIG. 4 is a schematic illustration of a PINS system 1006 according toyet another embodiment of the invention. In various embodiments, a PINSsystem 1006 may comprise an NSS 100; a daily living ART (DL-ART) system,apparatus, or device 600; and a TMC 800. The NSS 100 may comprise one ormore types of neural stimulation devices that are identical or analogousto those described above, for example, a set of electrodes or electrodeassemblies 120 coupled to an IPG 100; and a communication device 130,which may be configured for communication with the TMC 800 (e.g., by wayof a link 135) and/or another programming device (not shown). As furtherdescribed below, the TMC 800 may comprise a computer system that isconfigured and adapted to interface with the DL-ART system 600 andpossibly the NSS 100.

A DL-ART system 600 may comprise one or more instruments or objects ofdaily living (ODL) 610 that a patient 10 might encounter, use,manipulate, handle, and/or interact with in a normal daily situation; aset of interaction monitoring elements or devices (IMDs) 620 thatfacilitate the detection, characterization, and/or analysis of one ormore aspects of the patient's interaction with an ODL 610; and a controlmodule 650. The control module 650 may comprise hardware and/or softwareconfigured for signal acquisition, processing, and/or analysis, and maybe implemented using devices or elements that are separate from and/orcarried by or resident within the TMC 800. Referring also again to FIG.1B, in a representative embodiment, the control module 650 may compriseone or more I/O interfaces or ports 806; a circuit board within the TMC800 that carries circuit elements (e.g., signal conversion or signalprocessing circuitry and an electronically readable, configurable, orprogrammable medium) corresponding to DL-ART system operation; and oneor more sets of program instructions associated with or corresponding tothe IMDs 620 and/or the ATU 850, PAU 860, and/or SCU 870.

The IMDs 620 may be configured for wireless and/or wire-basedcommunication with each other, the control module 650, and/or the TMC800. Depending upon embodiment details, one or more IMDs 620 may becarried by the patient 10 and/or an ODL 610 as further described below.Based upon the detection and/or characterization of the patient'sinteraction with an ODL 610, the TMC 800 may measure, assess, orestimate patient performance relative to particular types of motion,activity, tasks or subtasks at one or more times. The TMC 800 maythereby generate and store baseline and periodic patient performanceinformation.

Based upon signals generated by particular IDMs 610, the TMC 800 maysynchronize or approximately synchronize neural stimulation and/ormonitoring operations with specific patient actions. In some embodimentsthe TMC 800 may initiate, query, continue, adjust, interrupt, resume,and/or terminate neural stimulation and/or monitoring operations in anadaptive, essentially adaptive, or generally adaptive manner based uponsignals generated by one or more IMDs 610. The TMC 800 may manageadaptive stimulation and/or monitoring operations in a real-time,near-real time, or delayed (e.g., from one behavioral activity attemptto a subsequent attempt, or one therapy period or treatment session to anext) manner. In a manner identical or analogous to that associated withother PINT embodiments described herein, such adaptive neuralstimulation may enhance an extent to which an individual experiencesneurofunctional development or restoration and/or increase a likelihoodthat neurofunctional gains are lasting or essentially permanent.

In general, activities of daily living may include putting on orremoving clothing; the preparation or consumption of beverages or meals;personal hygiene (e.g., brushing teeth or hair); household cleaning; theuse of various types of household devices, appliances, tools, orimplements (e.g., a telephone, scissors, or a screwdriver); hobbies(e.g., painting or knitting); and/or a wide variety of other typicalbehavioral activities. Any given ODL 610 may thus comprise an object ora version of an object that facilitates the performance or attemptedperformance of particular activities of daily living; and a set of IMDs620 carried by or mounted upon or within such an object. In certainembodiments, an ODL 610 may also comprise a power source (e.g., abattery or a capacitor) and power management circuitry corresponding tothe IMDs 620. As illustrated in FIGS. 4, 5A-5F, and 6, representativetypes of ODL 610 may correspond to a cup 610 a; a food item 610 b; atoothbrush 610 c; a jar 610 d; a writing implement 610 e; a button 610f; a pair of scissors 610 g; and an iron 610 h.

In addition to any IMDs 620 carried by an ODL 610, one or more IMDs 620may be carried by or mounted upon the patient 10. In the descriptionherein, IMDs 620 carried by the patient 10 are referred to aspatient-side IMDs 620 a; and IMDs 620 carried by an ODL 610 are referredto as object-side IMDs 620 b. In various embodiments, patient-side IMDs620 a may be carried by, mounted upon, and/or incorporated into one ormore wearable articles such as a sleeve or glove 622 and/or a set ofbands, rings, or clips 624 that surround or reside upon or proximate toportions of a patient's finger tips 26, fingers 24, hand 22, wrist, arm20, or other body part(s) in a manner indicated in FIG. 4. A wearablearticle may also carry a power source such as a battery or a capacitorand associated power management circuitry corresponding to one or morepatient-side IMDs 610 a.

IMDs 620 may facilitate the detection, characterization, and/or analysisof a patient's interaction with an ODL 610 in a wide variety of manners.For example, IMDs 620 may be configured and adapted to generate, output,and/or receive signals that facilitate proximity detection; surfacecontact sensing; position, orientation, and/or motion detection; forcemeasurement; and/or temperature sensing. Correspondingly, a DL-ARTsystem 600 may be implemented using various types electrical, magnetic,optical, ultrasonic, thermal, mechanical or micromechanical, and/orother technologies.

In some embodiments such as those illustrated in FIG. 4 or 6,patient-side IMDs 620 a and ODL-side IMDs 620 b may be configured forproximity or contact sensing, such that one or more IMDs 620 generateproximity or contact signals in a manner that corresponds to orindicates the presence and/or position(s) of particular patient fingertips 26 proximate to, at, or upon one or more portions of an ODL 610.Depending upon embodiment details, such patient-side and/or ODL-sideIMDs 610 a-b may comprise a set of electrical signal transfer devices(e.g., conductive surfaces or strips) that affect or establish a signallevel in response to circuit completion; RF or ultrasonic emitters,receivers, and/or transceivers; capacitive or field-effect touch sensors(e.g., a sensor comprising or based upon a device manufactured byTouchSensor Technologies of Wheaton, Ill.); and/or other types ofdevices. In certain embodiments employing one or more touch sensors,such sensors may be carried by the ODL 610 and patient-side IMDs 610 bmay be omitted, in which case the ODL 610 or its touch sensors 610 a maybe configured for wireless or wire-based signal communication with thecontrol module 650 and/or the TMC 800 (e.g., as indicated by the dashedline between the ODL 610 and the TMC 800 in FIG. 4).

The control module 650 and/or the TMC 800 may acquire, receive, store,process, and/or analyze proximity or contact signals at one or moretimes, possibly following the TMC's presentation of particularinstructions to the patient 10 (e.g., audio or visual requests to grasp,pick up, hold, manipulate, or release the ODL 610). The TMC 800 mayadditionally transfer patient performance information comprising orcorresponding to proximity or contact signals to a remote location suchas a networked computer system or storage device.

In certain embodiments, the TMC 800 may initiate, query, continue,adjust, interrupt, resume, or discontinue neural stimulation and/ormonitoring operations based upon 1) proximity or contact signals; andpossibly 2) the nature and/or extent of the patient's neurologicdysfunction and general or specific expected, observed, estimated, ormeasured patient functional limitations (e.g., one or more types of finemotor control) associated with such dysfunction. For example, a patient10 suffering from hemiparesis may experience significant difficultyperforming actions involving finger extension, and comparatively less orlittle difficulty performing actions involving finger flexion. Thus,after the TMC 800 has instructed the patient 10 to perform an actioninvolving finger extension, such as releasing a cup or appliance handle,the TMC 800 may direct the NSS 100 to apply neural stimulation signalsto the patient 10 using a set of stimulation parameters that mayfacilitate enhanced development of neurofunctional abilities thatsubserve finger extension.

Based upon one or more proximity or contact signals, the TMC 800 maydetermine that the patient 10 has grasped an ODL 610, or has extended orbegun to extend their fingers 24 to release the ODL 610. The TMC 800 maycorrespondingly instruct the NSS 100 to apply stimulation signals to thepatient 10 in an adaptive or essentially adaptive manner thatcorresponds to particular patient actions. For instance, the TMC 800 mayinstruct the NSS 100 to avoid neural stimulation or deliver stimulationsignals to the patient 10 in accordance with a first set of stimulationparameters during an activity or time interval associated with reachingor grasping the ODL 610; or initiate neural stimulation or deliverstimulation signals in accordance with a second set of stimulationparameters during an activity or time interval associated with releasingthe ODL 610. The second set of stimulation parameters may differ fromthe first set of stimulation parameters in one or more stimulationsites, signal polarities, peak signal levels, pulse widths, pulserepetition frequencies, interburst or intraburst patterns, signalmodulation operations or functions, and/or other parameters.

In a representative example, the first set of stimulation parameters mayspecify a unipolar or bipolar polarity; a peak current or voltage levelthat corresponds to 25% of a movement or sensation threshold level or apredetermined maximum stimulation level; a pulse repetition frequencybetween approximately 35 Hz and 200 Hz (e.g., 50 Hz); and a first phasepulse width between approximately 50 and 300 microseconds (e.g., 100,200, or 250 microseconds). The second set of stimulation parameters mayspecify a unipolar polarity; a peak current or voltage level thatcorresponds to 50% of a movement or sensation threshold level or apredetermined maximum stimulation level; a pulse repetition frequency of100 Hz; and a first phase pulse width of approximately 250 microseconds.The second set of stimulation parameters may additionally specifyparameters that result in the brief application of one or morenear-threshold, threshold, and/or suprathreshold pulses or bursts;and/or parameters that correspond to theta burst stimulation or anothertype of naturally occurring neural discharge behavior. Adapting orvarying neural stimulation in one or more of such manners based uponpatient activity and/or patient interaction with an object or device mayincrease a likelihood of providing enhanced and/or long lasting (e.g.,for weeks, months, years, or permanently) neurofunctional benefit.

In some embodiments, the IMDs 620 may be implemented using a set ofposition, orientation, and/or force tracking devices that may generateor communicate corresponding position, orientation, and/or forcesignals. The TMC 800 may receive, store, and/or analyze such signals,and possibly manage or control neural stimulation and/or monitoringoperations in an adaptive or generally adaptive manner in view of suchsignals.

For example, in certain representative embodiments such as those shownin FIGS. 4 and/or 6, some or each of the IMDs 620 and the control module650 may comprise or be based upon a motion tracking system, for example,a microBird™, miniBird™, pciBird™, and/or six degree of freedom (DOF)magnetic tracking system manufactured by Ascension TechnologyCorporation of Burlington, Vt. One or more IMDs 620 or motion trackingdevices or elements may be carried by the patient 10 and/or an ODL 610.Such devices can also be positioned or located at a distance from thepatient, for example, at particular locations within a room. In a manneranalogous to that previously described, in certain embodiments the TMC800 may adaptively direct neural stimulation and/or monitoringoperations in a manner that corresponds to the position, orientation,velocity, stability, and/or forces experienced by particular patientbody parts and/or ODLs 610.

As another example, FIG. 5D is a schematic illustration of an actual orsimulated writing implement 610 e having a set of IMDs 620 b thatcomprises a set of orientation and/or force sensors 626. The orientationand force sensors 626 may comprise one or more of a level sensor 626 a;an accelerometer and/or a gyroscope 626 b; and a force or pressuresensor 626 c. The orientation and force sensors 626 may be coupled to atransmitter 628 configured to communicate orientation and/or forcesignals to the control module 650 and/or the TMC 800.

In some embodiments, the writing implement 610 e may operate inassociation with a writing tablet coupled to the TMC 800, in a mannerunderstood by those skilled in the relevant art. The TMC 800 may displayexample symbols, characters, or pictures upon a display device 822;instruct the patient 10 to create patient-generated symbols, characters,or pictures using the writing implement 610 e; receive, store, and/oranalyze corresponding orientation and force signals; and displaypatient-generated symbols, characters, or pictures upon the displaydevice 822. Additionally, based upon the orientation and/or forcesignals, the TMC 800 may adaptively direct neural stimulation and/ormonitoring operations in a manner that corresponds to patientperformance in actions relating to writing, such as grasping and/orreleasing the writing implement 610 e, and/or applying vertical and/ortranslational forces to the implement 610 e.

While not shown in FIGS. 4, 5A through 5F, and 6, particular PINSembodiments 1006 may additionally comprise an SSM system or device 150that is identical, essentially identical, analogous, or similar to thatdescribed above with reference to FIG. 3. Such embodiments may provideparticular types of stimulation (e.g., FES) to the patient 10, and/orsense, measure, or monitor patient response and/or patient state signalsin one or more manners previously described (e.g., EEG, EMG,hemodynamic, and/or other types of signals). Moreover, certain SSMembodiments may comprise or include one or more implantedmicrostimulators as described above. In such PINS embodiments 1006, theTMC 800 may direct or oversee neural stimulation and/or monitoringoperations in an adaptive or approximately adaptive manner based uponinformation received from one or more IMDs 610 and/or the SSM.

As indicated above with reference to FIG. 4, in multiple embodimentsODLs 610 may interface with the TMC 800 in a direct or generally directmanner. In addition to items, instruments, or objects of daily living,various other types of devices or elements that may aid an individual'sneurofunctional development may interface with the TMC 800 in such amanner, possibly in association with cognitive or memory training,auditory training, visual training, speech or language training, and/orvirtual reality games, training, learning, or experiences as describedin detail hereafter.

FIG. 7 is an illustration of a PINS system 1008 according to anotherembodiment of the invention. In various embodiments, the PINS system1008 comprises an NSS 100; a TMC 800; one or more virtual ART (V-ART)systems, subsystems, devices, or elements 700 configured to interfacewith the TMC 800; and possibly an SSM system or device 150 that may alsoconfigured to interface with the TMC 800. In several embodiments, such aPINS system 1008 may be implemented using a computer workstation, adesktop computer, a laptop computer, a handheld computer, and/orparticular wearable computing or virtual reality devices.

The NSS 100 may comprise one or more neural stimulation devices that areidentical, analogous, or similar to those described above. Acommunication device 130 coupled to the TMC 800 or another programmingdevice may transfer signals to and/or receive signals from the NSS 100.In some embodiments, the TMC 800 may manage or direct neural stimulationand/or monitoring operations, possibly in an adaptive or approximatelyadaptive manner. In other embodiments, another programming device maymanage or direct neural stimulation and/or monitoring operations.

In several embodiments, a V-ART system or device 700 may comprise a setof interactive training tools, devices, structures, and/or elements thatprovide a given type of user interface in association or conjunctionwith the TMC 800. Particular portions of such devices, structures, andelements may comprise hardware and/or software, and may reside externalto and/or within the TMC 800, in a manner identical or analogous to thatfor other PINS systems 1000, 1002, 1004, 1006 described above.

Referring also to FIG. 1B, in various embodiments, interactive trainingtools may include particular types of general-purpose, standardized,and/or frequently encountered user interface or computing devices, suchas a keyboard 812, a mouse or trackball 814, a camera 816, a microphone818, speakers 824, and/or a display or visual presentation device 822.

Additionally or alternatively, interactive training tools may includeone or more devices that are configured and adapted for specific typesof training, learning, or simulation tasks, such as a haptic system,subsystem, or device 710; a digital glove 720; a musical instrument(e.g., a keyboard) 730; a set of foot pedals 740; a headset 750; and/ora digital writing tablet 760. Those skilled in the art will understandthat one or more of a microphone 818, speakers 824, and a visualpresentation device 822 may be carried by or incorporated into theheadset 750. Interactive training tools may be configured for wire-basedor wireless communication with the TMC 800.

The haptic device 710 may comprise a haptic input device 712 and varioustypes of sensors 714 (e.g., force sensor and motion that may detect upto six degrees of freedom) and actuators 715 and/or stimulation devices716 for providing tactile, proprioceptive, and/or various sensoryfeedback and/or forces against the patient's hand and/or arm movements.A digital glove 720 may facilitate the application or delivery ofparticular types of stimulation, feedback, or forces to the patient 10,and/or monitoring or measurement of forces or patient activity. Suchstimulation, feedback, and/or forces may comprise electrical, thermal,or vibratory signals and/or displacements in one or more translationaland/or rotational directions. In some embodiments, the haptic inputdevice 712 may be carried or supported by the support structure 718. Oneor more sensors 714, actuators 715, and/or stimulation devices 716 maybe carried by the haptic input device 712 and/or the support structure718. A detailed description of one type of haptic device 710 that may besuitable for use in particular embodiments of the invention is providedin U.S. Pat. No. 6,714,213, entitled “System and Method for ProvidingInteractive Haptic Collision Detection”, incorporated herein byreference in its entirety.

A detailed description of another type of haptic system or device 710that may be suitable use in several embodiments of the invention isprovided by Priyamvada Tripathi, Kanav Kahol, Leslie C. Baxter et al.,in “Rehabilitation of patients with hemispatial neglect usingvisual-haptic feedback in virtual reality environment,” InternationalConference on Human-Computer Interaction, HCII 2005, incorporated hereinby reference in its entirety. A PINS system 1008 that includes such ahaptic system or device 710 may apply neural stimulation in one or moremanners to particular target neural populations in a patient's brainbefore, during, and/or after the patient 10 performs or attempts toperform multimodal virtual reality haptic rehabilitation activities(e.g., cancellation, tracking, and/or assembling tasks and/or otheractivities) directed toward restoring neural function that has beenaffected or lost as a result of a neglect disorder. Such a PINS system1008 may include one or more types of motion tracking systems, in amanner analogous to that described above.

Referring also to FIG. 1B, the ATU 850 and/or the PAU 860 may manage thepresentation of auditory, visual, and/or other information to thepatient 10 to facilitate various types of rehabilitation and/or trainingtask or activities. In some embodiments, the ATU 850 and/or the PAU 860may include a set of program instructions directed toward interpretingor processing haptic device input, and/or selecting or providing giventypes of haptic stimulation or feedback to the patient 10. Based uponthe patient's interaction with the haptic device 710, the ATU 850 mayadaptively select or adjust particular types of training or taskscenarios presented to the patient 10. Moreover, in certain embodiments,the SAU 870 may exchange signals with the communication device 130 toadaptively adjust neural stimulation and/or monitoring operations basedupon patient performance or patient interaction with the haptic device710. Adjustment of patient training or task scenarios and/or neuralstimulation or monitoring operations may occur on a real time ornear-real time basis, or on a time delayed basis (e.g., from onetraining session or therapy period to another).

A musical instrument 730 may comprise a keyboard or synthesizer, a setof electronic drums, and/or other types of actual or mock-upinstruments. A musical instrument 730 such as a musical keyboard mayalso comprise one or more foot pedals 740. Particular musicalinstruments 730 may support, operate, and/or generate digitalinformation in accordance with a Musical Instrument Digital Interface(MIDI) and/or other format.

Relative to elements illustrated in FIG. 1B, the ATU 850 may manage thegeneration and presentation of an interactive musical interface to thepatient 10. The musical interactive interface may present instructionalimages, videos, and/or sounds to the patient 10 (e.g., to instruct thepatient 10 to play certain musical notes, chords, or sequences); andpossibly relayed, captured, or recorded images 805, videos, and/orsounds corresponding to real time, near-real time, or prior patient useof a musical instrument 730. Sounds may be presented by the musicalinstrument 730 and/or the speakers 824, which may be implemented usingheadphones or the headset 750.

The ATU 850, possibly in association with the PAU 860, may test, score,and/or evaluate the patient's functionality (e.g., in relation to finemotor skills, memory, cognition, or awareness) or progress at one ormore times, and store or transfer such information for subsequent review(e.g., by a clinician). Tests of patient functionality may be directedtoward determining patient proficiency in tasks, patterns, or sequencesthat the patient 10 has already practiced, and/or tasks that are new orunfamiliar to the patient 10 to facilitate the evaluation of one or moreaspects of the patient's neurofunctional condition. Based upon patientperformance, the ATU 850 may select or adjust particular types of tasksor activities, and/or the SAU 870 may adjust neural stimulation and/ormonitoring operations in a manner identical or analogous to thatdescribed above.

In several embodiments, standard types of computing devices such as akeyboard 812, a selection device such as a mouse or trackball 814, amicrophone 818, a display device 822, and/or speakers 824 may serve asinteractive training tools. In such embodiments, the ATU 850 may directthe presentation of various types of textual, auditory, and/or visualinformation (e.g., images, scenes or scene sequences, or videos) to thepatient 10 to facilitate particular types of training or rehabilitationactivities. Such training may be directed toward, for example, typingskills, language skills, visual training, memory training, and/or otheractivities that facilitate neurofunctional development and/orassessment.

In a representative example, the ATU 850 may manage the presentation ofa video game to the patient 10. In another representative example, theATU 850 may direct the presentation of one or more memory orintelligence tests; and/or textual information and a correspondingcomprehension test to the patient 10. In another representative example,the ATU 850 may present a patient 10 suffering from symptoms associatedwith stroke, TBI, or Alzheimer's disease with scenes, scene sequences,and/or video images corresponding to an environment with which thepatient 10 may have at least some familiarity. Such scenes or videoimages may comprise, for example, portions of prerecorded videos of thepatient's home and various neighborhood landmarks, and simple navigationpaths between such locations. The ATU 850 may instruct the patient 10 totravel to particular destinations by selecting particular traveldirections using arrow keys on the keyboard 812 or mouse movement, andupdate scenes or scene sequences as the patient 10 virtually navigatestheir neighborhood. The PAU 860 may correspondingly process or evaluatepatient performance.

The NSS 100 may apply or deliver one or more forms of neural stimulationto the patient before, during, and/or after the patient 10 interactswith the PINS system 1008. Based upon patient input received from aninput device 810 such as the keyboard 812 or mouse 812, the ATU 850and/or the PAU 850 may select, adjust, or update the presentation ofinformation to the patient 10. Furthermore, in certain embodiments theSAU 870 may adjust neural stimulation and/or monitoring operationsduring the presentation of such information to the patient 10 in amanner that may correspond to received, processed, and/or analyzed inputdevice signals.

As indicated above, various embodiments of the PINS system 1008 mayinclude an SSM system or device 150 configured for stimulation and/ormonitoring operations in one or more manners identical or analogous tothose described above. For example, an SSM device 150 may include a setof monitoring devices such as a heart rate monitor, EEG electrode, orblood oxygenation sensor that are worn by the patient or carried by aninteractive training tool such as a headset 760. The ATU 850 and/or thePAU 860 may process and/or evaluate signals received from suchmonitoring devices, and may possibly present such signals to the patientin a manner that facilitates biofeedback training. In some embodiments,the SAU 870 may adjust neural stimulation and/or monitoring operationsbased upon SSM device signals.

In addition to the foregoing, other types of PINT systems and/or methodsdirected toward virtual reality training or therapy may be comprisevarious types of wireless and/or wire-based systems, subsystems,devices, and/or elements configured to generate an immersive virtualreality environment. Such systems or devices may comprise a fullyimmersive six-sided virtual reality theater, in which individuals maymove about, possibly while their motions are tracked based upon signalsreceived from devices the individuals carry or wear. An integratedvirtual reality environment that may be suitable for particular PINTembodiments is described in detail by Galen Faidley et al., in“Developing an Integrated Wireless System for Fully Immersive VirtualReality Environments,” (Proceedings of the Eighth InternationalSymposium on Wearable Computers, ISWC 2004).

As an alternative or in addition to various embodiments described above,particular PINT systems may be adapted and configured for therehabilitation or development of lower extremity function. FIG. 8 is aschematic illustration of another embodiment of a PINS system 1100 inaccordance with the present invention. In one embodiment, the PINSsystem 1100 comprises an NSS 100, a TMC 800, and a lower extremity ART(LE-ART) device 900. The system 1100 may also comprise an SSM device150, as further described below.

The NSS 100 may comprise one or more types of neural stimulation devicesdescribed above, and may receive signals from and/or transfer signals toa communication device 130 that may be coupled to the TMC 800 or anotherprogramming device. In a manner identical or analogous to that describedabove, in certain embodiments the TMC 800 may affect or direct neuralstimulation and/or monitoring operations, possibly in an adaptive orpatient performance responsive manner.

The LE-ART device 900 may comprise a lower limb motion (LLM) apparatus950 which may be configured to engage a patient 10 in particular typesof lower extremity motion or movement patterns. A treadmill typemechanism is illustrated in the instant embodiment; however, it is to beappreciated that in various embodiments, other configurations may beemployed such as a stair climbing apparatus, a stationary bicycle, asimulated skiing apparatus, a trampoline-type apparatus, and/or anothertype of device. In a treadmill type configuration as illustrated, theLLM apparatus 950 may initiate or adjust the operation of a movementplatform 952 in response to patient motion or pressure. The LLMapparatus 950 may include a set of arm rails 954 to provide support tothe patient 10 as needed.

In certain embodiments, one or more portions of the TMC 800 may becarried by or mounted upon the LE-ART device 900. For example, a displaydevice 822 may be mounted upon the LLM apparatus 950 in a manner thatreadily facilitates patient viewing of instructions or information(e.g., a simulated scene and/or a display of signals corresponding topatient activity such as estimated distance traveled) while the patientwalks or attempts to walk. Additionally, one or more other portions ofthe TMC 800 may be carried by the LE-ART device 900, such as a housingin which various TMC hardware and/or software resides, and/or acommunication device 130. In an alternate embodiment, the communicationdevice 130 may be carried by a sleeve, cuff, collar, harness, or otherpatient wearable item.

An SSM system or device 150 in such a PINS embodiment 1100 may compriseone or more gait sensors 158 and/or patient state sensors 159. The gaitsensors 158 may be carried by, mounted upon, or worn by the patient 10,and may comprise, for example, a set of accelerometers, gyroscopes,and/or other elements. In a representative embodiment, a gait sensor 158may comprise or be base upon an activity sensor described by EmilJovanov et al., in “A wireless body area network of intelligent motionsensors for computer assisted physical rehabilitation,” Journal ofNeuroEngineering and Rehabilitation, 2005, 2:6. An SSM system 150 mayitself comprise or interface with a body area network that includes oneor more wireless devices that are mounted upon the patient 10.

Patient state sensors 158 may comprise devices configured to sensepatient heart rate, temperature, blood flow, blood oxygenation orchemical composition characteristics, and/or other patient relatedparameters. Patient state sensors 159 may be carried by or mounted uponthe patient 10 or the LE-ART device 900 (e.g., on an arm rail 954).

The LE-ART device 900 and the SSM device 150 may generate and transfersignals corresponding to patient performance and state to the TMC 800.The ATU 850 and/or the PAU 860 may process, analyze, characterize,store, and/or transfer (e.g., to a remote clinician system) suchsignals. Signals or information associated with the LE-ART device 900and/or the SSM device 150 may provide clinicians or physicians withvaluable gait, posture, and overall movement data regarding a patient'sneurofunctional state or development.

The ATU 850 and/or the PAU 860 may select or adjust particular types oflower extremity activities based upon patient state signals or patientperformance information. Additionally or alternatively, the SAU 870 mayadjust or affect neural stimulation and/or monitoring operations basedupon patient state signals and/or patient performance information.

As indicated above, various embodiments of the present invention maycomprise different types of neural stimulation systems, devices, and/orelements. FIG. 9 is a schematic illustration of a PINS system 1100directed toward providing transcranial neural stimulation in accordancewith an embodiment of the invention. In various embodiments, a PINSsystem 1100 may comprise a transcranial stimulation system (TSS) 1110; aTMC 800; and possibly an AC-ART device 400 and/or an SSM system ordevice 150. The TSS 1110 may comprise, for example, a TMS system and/ora tDCS system. In particular embodiments, the TMC 800 may be configuredfor signal communication with the TSS 1110, the AC-ART device 400,and/or the SSM device 150 at one or more times.

The AC-ART device 400 may comprise one or more types of elements ordevices identical or analogous to those described above with referenceto FIG. 2, including a controller 450 for controlling various the AC-ARTdevice functions. The controller may be coupled to the TMC 800 by a link452. Furthermore, the SSM device 150 may comprise one or more types ofelements identical or analogous to those previously described, which maybe coupled to the TMC 800 by another link 155. In certain embodiments inwhich an AC-ART device 400 lacks FES capabilities, the SSM device 150may provide such capabilities.

The TSS 1110 may comprise one or more types of signal generation,transfer, and/or application devices or elements configured to deliverstimulation signals transcranially; a control module 1120 for directingthe generation and delivery of such signals; and a power source, powerdelivery circuitry, and/or power management circuitry. The TSS 1110 mayfurther comprise a structure that may be worn about or proximate to oneor more areas selected for neural stimulation, and which carries thecontrol module 1120, the associated signal generation and applicationelements, and the power related elements.

In some embodiments employing transcranial magnetic stimulation (TMS), ahousing 1112 may be configured as a helmet that carries one or moremagnetic coils 1114, the control module 1120, and possibly a powersource and associated circuitry. The magnetic coils 1114 may bepositioned at or relative to one or more stimulation sites, such thatmagnetic stimulation pulses may be applied to particular cortical and/orsubcortical target neural populations or neural structures. The controlmodule 1120 may direct the generation of magnetic pulses in accordancewith various stimulation signal parameters, such as peak magnetic fieldintensity, pulse repetition frequency, and a pulse sequence duration orpulse count. In a representative embodiment, the TSS 110 may comprise orbe based upon a helmet-type TMS system as described in U.S. Pat. No.6,402,678, entitled “Means and Method for the Treatment of MigraineHeadaches,” incorporated herein by reference in its entirety.

In a manner that is identical, essentially identical, or analogous tothat described above, the TSS 1110 may apply or deliver stimulationsignals to the patient 10 before, during, and/or after the TMC 800presents the patient 10 with auditory and/or visual informationcorresponding to particular types of tasks or activities. The TSScontrol module 1120 may be configured for wireless or wire-basedcommunication with the TMC 800, for example, by way of a link 1125. Suchcommunication may involve the transfer of configuration data,stimulation parameters, power signals, and/or other signals.

The AC-ART device 400 may comprise an assistive clothing articleconfigured for wearing on a patient body part at a location that isrelevant to one or more types of neurofunctional activity or developmentunder consideration. The AC-ART device 400 may be structurally and/orfunctionally identical, essentially identical, or analogous to thatdescribed above with reference to FIG. 2. In some embodiments, the TSScontrol module 1120 may be coupled to the AC-ART device 400 and/or theSSM device 150, such that the TSS 1110 may apply transcranialstimulation signals to the patient 10 in a manner that is timed orsynchronized relative to AC-ART and/or SSM device operation.

The TSS 1110, the AC-ART device 400, and/or the SSM device 150 maytransfer signals to the TMC 800. In response, the TMC 800 may process,analyze, or characterize such signals and generate corresponding patientperformance data or information. Additionally, the TMC 800 may store ortransfer patient performance information to a remote computer system.

The TMC 800 may select and/or adjust particular types of tasks ortherapeutic activities based upon received signals and/or patientperformance information, in a real-time, near-real time, or delayedmanner. Additionally, in one or more manners describe above, in certainembodiments the TMC 800 may initiate, query, modify, interrupt, resume,continue, or terminate operation of the TSS 1110, possibly based upon atype of patient task or rehabilitative training under considerationand/or signals associated with patient performance.

In a representative embodiment wherein an assisted clothing article isadapted to be worn on a hand 22, as shown, patient training may bedirected toward performing tasks while manipulating and/or using thehand 22. One example of such a task may involve the patient simulatingan ADL like buttoning a shirt. The TSS 1110 may apply one or more typesof stimulation signals before, during, and/or after the patient 10performs or attempts to perform the task. The AC-ART device 400 and/orthe SSM device 150 may provide assistive peripheral stimulation in amanner previously described. For instance, while the patient 10 isengaging in a shirt buttoning activity, transcranial stimulation pulsesmay be delivered by TSS 1110, and functional electrical stimulationpulses may be delivered directly to the hand 22 while the AC-ART device400 possibly provides mechanized movement assistance for the hand 22. Inother embodiments, the TSS 110, the AC-ART device 400, and/or the SSMdevice 150 may be operate sequentially or individually during taskperformance, or in various combinations relative to the performance ofsingle or multiple task attempts or repetitions to enhance a likelihoodof achieving a desired therapeutic effect.

Representative PINS-ACT System Embodiments

As indicated above, neural stimulation may be combined with multipletypes of adjunctive therapy, which may include behavioral therapiesand/or chemical substance therapies. One or more chemical substancetherapies may be applied or delivered to a patient 10 simultaneouslywith or separately from neural stimulation and/or behavioral therapy.Moreover, one or both of neural stimulation signal and chemicalsubstance delivery may be controlled or modified in an adaptive manner,either separately, concurrently, or somewhat concurrently.

FIG. 10A is a schematic illustration of a PINS-ACT system 2000 accordingto an embodiment of the invention. Relative to FIGS. 1A and 1B, likereference numbers indicate like or analogous elements. In oneembodiment, the PINS-ACT system comprises a neural stimulation andchemical delivery (NSCD) system 2500; one or more types of ART devices,such as essentially any ART device previously described; and a TMC 800.

The NSCD system 2500 may comprise a set of neural stimulation devices orelements 2510 and a set of substance delivery devices or elements 2520coupled to a control module 2550. The neural stimulation elements 2510may comprise one or more electrode devices and/or signal transferelements, in a manner identical or analogous to that described above.Depending upon embodiment details, the substance delivery elements 2520may comprise one or more of a chemical source or reservoir, a fluid orsubstance transfer element (e.g., a catheter and/or a port), and asubstance application mechanism. The NSCD system 2500 may furthercomprise one or more monitoring devices for sensing, detecting, and/ormeasuring signals and/or substances (e.g., chemical levels and/orbiological markers) associated with neural stimulation, chemicalsubstance delivery, and/or patient state.

Neural stimulation elements 2510 may be positioned or implanted relativeto a set of neural stimulation sites, and substance delivery elements2520 may be positioned relative to a set of substance application sites.A substance application site may correspond to an anatomical locationthat is essentially identical to, near, or different from a neuralstimulation site.

The control module 2550 may comprise an implantable housing that carriescontrol circuitry for directing the operation of the neural stimulationelements 2510 and chemical delivery elements 2520; communicationcircuitry; and power circuitry. The control module 2550 may beconfigured for wireless signal transfer with a communication device 132,which may be coupled to a TMC 800 and/or another type of programmingdevice.

FIG. 10B is a block diagram of a TMC 800 according to an embodiment ofthe invention. Relative to FIG. 1B, like reference numbers indicate likeor analogous elements. The TMC 800 and/or the ART device may operate inone or more manners previously described to engage the patient inparticular types of activities directed toward restoring or enhancingneural function. The TMC 800 and/or the ART device may capture, acquire,receive, process, and/or analyze signals corresponding to patientperformance and/or patient state. In certain embodiments, the TMC 800and/or an ART device may direct the NSCD system 2500 (FIG. 10A) toinitiate, query, adjust, interrupt, resume, continue, and/or terminateneural stimulation and/or chemical substance delivery operations basedupon such signals. Such direction may occur on a real time, non-realtime, or delayed basis, in one or more manners previously described.Depending upon embodiment details, neural stimulation parameters mayremain unchanged while substance delivery parameters are updated ormodified; substance delivery parameters may remain unchanged whileneural stimulation parameters are modified; or both neural stimulationand substance delivery parameters may be modified, possibly in aninterrelated and/or simultaneous manner.

While the PINS-ACT system 2000 is shown in FIG. 10A in relation to anembodiment that is analogous to the PINS system 1000 shown in FIG. 1A,an NSCD system 2500 may be employed in essentially any type systemdescribed above with reference to FIGS. 1A through 9.

Representative PICT System Embodiments

In certain embodiments of the invention, one or more chemical substancesmay be applied to a patient 10 in lieu of neural stimulation. Inassociation with a chemical substance therapy, the patient 10 mayperform one or more types of behavioral activities that may be relevantto restoring or enhancing neural function.

FIG. 11A is a schematic illustration of a PICT system 2100 according toan embodiment of the invention. Relative to previously describedFigures, like reference numbers indicate like or analogous elements. Inone embodiment, a PICT system 2100 comprises a substance delivery system(SDS) 2600; one or more types of ART devices, such as essentially anyART device previously described; and a TMC 800.

The SDS 2600 may comprise an implantable drug pump or other deviceconfigured to dispense, release, or deliver one or more chemicalsubstances. In one embodiment, the SDS 2600 comprises a set of substancedelivery elements 2620 coupled to a control module 2650. The SDS 2600may further comprise one or more monitoring devices, in a manneranalogous to that described above. The SDS 2600 may be configured forwireless signal transfer with a communication device 134, which may becoupled to the TMC 800 or another programming device.

FIG. 11B is a block diagram of a TMC 800 according to an embodiment ofthe invention. Relative to FIG. 1B, like reference numbers indicate likeor analogous elements. The TMC 800 and/or the ART device may operate inone or more manners previously described to engage the patient inparticular types of activities directed toward restoring or enhancingneural function. The TMC 800 and/or the ART device may capture, acquire,receive, process, and/or analyze signals corresponding to patientperformance and/or patient state. In certain embodiments, the TMC 800and/or an ART device may direct the SDS 2600 to initiate, query, adjust,interrupt, resume, continue, and/or terminate chemical substancedelivery operations based upon such signals. Such direction may occur ona real time, non-real time, or delayed basis, in one or more mannerspreviously described.

While the PNCT system 2100 is shown in FIG. 11A in relation to anembodiment that is analogous to the PINS system 1000 shown in FIG. 1A, aSDS 2600 may be employed in essentially any type of system describedabove with reference to FIGS. 1A through 9.

Representative PINT Procedures

FIG. 12 is a flow diagram illustrating a procedure or process 3000 forinteractive neural stimulation and/or substance delivery according to anembodiment of the invention. Process 3000 may comprise various processportions, particular aspects of which are described in detail hereafter.

Process portion 3010 may be directed toward configuring particularneural stimulation and/or substance delivery devices; one or morebehavioral therapy systems or devices (e.g., ART devices described aboveand/or ODLs 610); and/or particular SSM devices for operation. Processportion 3010 can include selecting particular stimulation, substancedelivery, and/or monitoring parameters; or selecting or initializingcertain behavioral therapy devices, tasks, tests, and/or virtualscenarios. Process portion 3010 can further include positioning orlocating a patient 10 for ART device operation. Process portion 3020 isdirected toward configuring a TMC for operation, which may includeloading and/or initializing particular software for communicating withthe ART device, an NSS 100, an NSCD system 2500, and/or a SDS 2600.

Process portion 3030 can include applying neural stimulation signalsand/or a chemical substance to the patient 10, and process portion 3040can include engaging the patient 10 in an interactive therapy, task,activity, test, and/or virtual or simulated environment by way of an ARTsystem or device and/or the TMC 800.

Process portion 3050 can include monitoring various types of patientperformance related signals, patient responses, and/or biologicalsignals or markers associated with neural stimulation, chemicalsubstance delivery, and/or patient performance or attempted performanceof an interactive activity, in particular manners such as thosedescribed above. Process portion 3050 can include processing oranalyzing such signals to determine or estimate a level of patientperformance, the patient's neurofunctional condition, and/orneurofunctional gains over time.

Process portion 3100 can include determining whether to discontinue orinterrupt a behavioral therapy or activity, possibly based uponmonitored signals and/or patient performance, or patient completion ofan activity. If so, process portion 3110 can include stopping orinterrupting the operation of an ART device. In the event thatbehavioral therapy is to continue, process portion 3120 can includedetermining whether to adjust a behavioral therapy, task, test, orvirtual scenario, possibly based upon monitored signals and/or patientperformance information. Process portion 3130 can include adjustingbehavioral therapy in one or more manners described above.

Process portion 3200 can include determining whether to discontinue orinterrupt neural stimulation and/or chemical substance delivery,possibly based upon monitored signals, patient performance, patientcompletion of particular tasks, and/or an expiration of a time period orinterval. If so, process portion 3210 can include discontinuing orinterrupting neural stimulation and/or chemical substance delivery,after which the process 3000 may end.

Process portion 3220 can include determining whether to adjust neuralstimulation and/or chemical substance delivery, possibly based uponmonitored signals, patient performance, patient completion of particulartasks, and/or an expiration of a time period or interval. If so, processportion 3210 can include adjusting neural stimulation and/or chemicalsubstance delivery in one or more manners described above. During and/orfollowing an adjustment or modification of neural stimulation and/orchemical substance delivery parameters, particular process portions maycontinue to function in one or more manners previously described.

From the foregoing, it will be appreciated that specific embodiments ofthe invention have been described herein for purposes of illustration,but that various modifications may be made without deviating from theinvention. For example, further embodiments of related systems andmethods are disclosed in the following copending patent applications,filed concurrently herewith and incorporated herein by reference: U.S.patent application Ser. No. 11/254,060, titled “Methods and Systems forImproving Neural Functioning, Including Cognitive Functioning andNeglect Disorders”; U.S. patent application Ser. No. 11/737,673, titled“Methods and Systems for Establishing Parameters for NeuralStimulation”; and U.S. patent application Ser. No. 11/583,349, titled“Neural Stimulation and Optical Monitoring Systems and Methods”. Aspectsof the invention described in the context of particular embodiments maybe combined or eliminated in other embodiments. Further, whileadvantages associated with certain embodiments of the invention havebeen described in the context of those embodiments, other embodimentsmay also exhibit such advantages, and not all embodiments neednecessarily exhibit such advantages to fall within the scope of theinvention. Accordingly, the invention is not limited except as by theappended claims.

We claim:
 1. A system for facilitating limb movement in a patient thatis suffering from or has suffered a neurological disorder or event; thesystem comprising: a neural stimulation system having an implantablepulse generator that is coupled to at least one electrode assemblycapable of delivering electrical pulses to the patient's brain; arobotic system configured to facilitate movement of the patient's limb;a control system operatively coupled to the robotic system and theneural stimulation system, the control system having a computer-readablemedium having instructions, wherein the instructions include:automatically receiving information from the robotic system, theinformation being correlated with the patient's performance of a taskusing the robotic system; and based at least in part on the informationreceived from the robotic system, automatically controlling a parameterin accordance with the neural stimulation system or the robotic systemto facilitate limb movement.
 2. The system of claim 1 wherein therobotic system comprises at least one robotic element that is positionedto resist patient movement under direction of the control system.
 3. Thesystem of claim 1 wherein the robotic system comprises the at least onerobotic element that is positioned to assist patient movement underdirection of the control system.
 4. The system of claim 1 wherein thepatient has suffered a stroke.
 5. The system of claim 1 wherein thepatient is suffering from Parkinson's disease.
 6. The system of claimwherein the patient is suffering from hemiparesis, spasticity, neglect,bradykinesia or a combination thereof.
 7. The system of claim 1 whereinthe electrode assembly is positionable under the skull and over the duraof a cortical target selected from a group consisting of motor cortex,premotor cortex, somatosensory cortex, and prefrontal cortex.
 8. Thesystem of claim 1 further comprising a secondary stimulation system. 9.The system of claim 1 wherein the robotic system comprises an element orelements to assist in restoration of hand movement, arm movement or acombination thereof.
 10. The system of claim 9 wherein the elementcomprises at least one arm member, at least one elbow member coupled tothe at least one arm member to form rotational axes, a set of actuatorsconfigured to facilitate arm member motion, a set of sensors configuredto sense and quantify position, force, speed, of arm members or elbowjoints, at least one gripping portion configured for grasping, or acombination thereof.
 11. The system of claim 1 wherein the roboticsystem comprises an element or elements to sense, analyze, monitor or acombination thereof the patient's interaction with an object of dailyliving.
 12. The system of claim 11 wherein the element is associatedwith a wearable item by the patient.
 13. The system of claim 12 whereinthe wearable item is a glove having the element configured as a set ofbands that is proximate to a portion of the patient's fingers, hand,wrist, arm or a combination thereof.
 14. The system of claim 12 whereinthe wearable item is a sleeve having the element configured as a set ofbands that is proximate to a portion of the patient's fingers, hand,wrist, arm or a combination thereof.